Keywords: Synthetic Controls, Clinical trials, Bayesian Analysis, Bayesian Designs, Bayesian Synthetic Controls, External Evidence, Historical Data
Room: Madison A
Pharmaceutical drug development requires testing of the efficacy and safety of novel compounds in clinical trials. Often, data have been collected in historical clinical trials involving the same control therapy, standard of care or placebo, or a similar investigational product, perhaps in the same drug class. We refer to this patient-level, historical clinical trial data, as Synthetic Control data. When this data is available, borrowing of information from history using Bayesian methods may make future trials more efficient. At our roundtable, we will be discussing: (1) What innovative role can Bayesian Synthetic Control methods play in facilitating drug development, while also minimizing overall patient burden? (2) Are there particular challenges or problems in drug development that Bayesian Synthetic Control methods are uniquely positioned to solve? (3) What are the recent methodological developments in the Bayesian statistical literature most suited for application in clinical trials? (4) What are the anticipated practical and technical challenges in incorporating Bayesian Synthetic Control methods into clinical trials?